Asheesh Sachdeva Email & Phone Number

•Planning and Budgeting of Phase III Clinical Trials•CRF designing•Investigator and Laboratory identification and selection•Conduct pre trial site evaluation, site initiation, monitoring and site close-out visits in compliance with the company SOPs and GCP•Source data verification•Data query resolution•Preparing monitoring plan•Expedited reporting of SAE to DCGI, Ethics committee and other investigators•Reporting safety information and protocol deviations to ethics committees•Preparation of Clinical Research Standard Operating Procedures•Co-ordinate payments for Investigators, laboratories, vendors•Vendor Selection for translations, printing, procurement of equipments etc.•Review and analysis of quotations received from Clinical Research Organization’s for global clinical trial projects•Maintaining relations with sponsor for providing project updates•Preparation of Investigator brochures for India generics•Writing final multicentric Phase III Clinical Study Report and Post Marketing Surveillance reports